Driver-guided Ablation of Persistent Atrial Fibrillatiom

Persistent Atrial Fibrillation Clinical Trial

Official title:

Driver-guided Ablation in the Treatment of Persistent Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04085731
• Other study ID #: Persistent AF Ablation
• Status: Recruiting
• Start date: September 21, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2023
• Source: IRCCS Policlinico S. Donato
• Contact: Carlo Pappone, MD
• Phone: +39 02 52774260
• Email: carlo.pappone[@]af-ablation.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a prospective, single-center, study. A targeted number of 181patients with persistent AF will be included according to pre-defined criteria. The ablation procedure consists on the identification of the arrhythmic substrate using a novel integrated mapping technique. We hypothesize that such approach may potentially lead to a mechanisms-targeted ablation strategy of persistent AF.

Description:

This is a prospective, single-center, study enrolling a total of 181patients with persistent AF according to well defined inclusion and exclusion criteria. The ablation procedure consists on the identification of the arrhythmic substrate using a novel integrated 3D mapping technique followed by standard CPVA at the end of the procedure. We will ablate substrates showing fast and regular electrical activities, starting from areas with the fastest mean cycle length and/or areas that have consistent rotational or focal propagation pattern and/or areas that comprise the slow conduction zone of possible arrhythmia circuits. After substrate ablation and AF termination, arrhythmia inducibility will be assessed and, if not inducible, the procedure will be completed by standard CPVA. If AF is still inducible, a new 3D map will be performed to identify further targets to be eliminated. Electrical cardioversion may be done at the end of the procedure. We hypothesized that such approach may potentially lead to a mechanisms-targeted ablation strategy leading to elimination of arrhythmic sources in individual patients, thus improving their clinical outcome. We will also characterize, identify and target the real pathophysiological substrates. After ablation, AF recurrence will be assessed by implantable loop recorder or thans-telephonic ECG recording from the end of the 3 months blanking period to 12 months following the procedure.The duration of this study is expected to be 24 months, from the first patient enrollment to the last patient follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 181
• Est. completion date: December 30, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria: Age (18-85 years), persistent AF according to ESC/EHRA guidelines, first or second ablation procedure, ability to provide informed written consent.

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Exclusion Criteria: Secondary AF, Hyperthyroidism, LVEF<30%, NYHA functional class IV, uncorrected valvular heart diseases, contraindication to anticoagulation, left atrial thrombus, recent (<6 months) myocardial infarction, thoracic surgery for congenital, valvular diseases, History of cerebrovascular events, pregnancy, cancer or other significant comorbidities.

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Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation
Driver-guided catheter ablation of persistent atrial fibrillation

Locations

Country	Name	City	State
Italy	IRCCS Policlinico S. Donato	San Donato Milanese	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from any AF or atrial tachycardia assessed from the end of the months blanking period to 12 months after ablation.	AF recurrences will be documented by implantable loop recorder or trns-telephonic ECG recording	12 months after ablation
Secondary	Identification of electrophysiological substrate	Areas with fast but regular activities or with consistent wave front propagation pattern, or with low P-P voltage, or complex fractionated electrograms	during the procedure
Secondary	inducibility of AF after the procedure	programmed atrial stimulation before and after isoproterenol	during the procedure
Secondary	AF burden	Assessment of AF burden by trans-telephonic ECG recording or implantable loop recorder	12 months after ablation